Effectiveness of a Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults with Prediabetes: Rationale and Study Protocol (Sweetch app)

  • STATUS
    Recruiting
  • sponsor
    Sweetch Health, LTD
Updated on 25 March 2021

Summary

Effectiveness of a Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults with Prediabetes: Rationale and Study Protocol (Sweetch app)

Description

The overall study will consist of two parts conducted in tandem: This Pilot Study is a 3-month pilot RCT study to test the feasibility of the Sweetch app in combination with a digital body weight scale (DBWS), with both groups receiving usual care for prediabetes.

This research is being done to see how well a mobile phone application (app) in combination with a digital body weight scale (DBWS) helps people with prediabetes monitor and manage their activity, nutrition, weight, and other measures to improve their health. Cardiovascular complications associated with type 2 diabetes begin at the prediabetes stage, and more than half of individuals with prediabetes will eventually develop diabetes.

Details
Condition Diabetes Prevention
Clinical Study IdentifierTX149311
SponsorSweetch Health, LTD
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults aged 18 -75 years with prediabetes (fasting BG 100-125 mg/dl, A1C 5.7% - 6.4%)
Body mass index 24-40 kg/m2 (BMI 22-40 kg/m2 for Asian individuals)
English speaker
Smartphone user (Android or Apple 5S and above)

Exclusion Criteria

Currently doing more than 150 minutes/week of moderate/vigorous physical activity
Presence of medical conditions that prevent adoption of moderate physical activity
Weight > 400 lbs
Use of any glucose-lowering or weight loss medications within the previous 3 months
Current pregnancy (self-reported) or planning pregnancy during study period (self-reported)
Presence of any condition that can result in spurious A1C readings (e.g. anemia [hemoglobin level below lower limit of normal] secondary to iron, vitamin B12, or folate deficiencies; hemoglobinopathies)
Use of systemic glucocorticoids
Use of antipsychotic medications (stable doses for at least three months of anti-depressants or anti-anxiety drugs will be allowed)
Severe mental illness or learning disability
Current participation in a clinical trial related to nutrition, physical activity, weight loss, or diabetes prevention
Liver enzymes > 3 x upper limit of normal
Prior diagnosis of diabetes mellitus
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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